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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameC-FLEX ASPHERIC INTRAOCULAR LENS MODEL 970C
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantRAYNER SURGICAL INC
PMA NumberP060011
Supplement NumberS002
Date Received09/26/2011
Decision Date11/22/2011
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of an aspheric optical surface to the anterior surface of the parent c-flex aspheric intraocular lens model 570c, as well as the addition of a modulation transfer function (mtf) figure to the physicians labeling comparing both models (i. E. , 970c and 570c).
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